Oral Cavity Squamous Cell Carcinoma Clinical Trial
— BiofeedbackOfficial title:
Rehabilitation of Head and Neck Cancer Patients With Biofeedback Training to Improve Speaking and Eating in Public
Verified date | March 2024 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Tongue cancer requires resection and reconstruction that can leave patients disabled with respect to speaking and eating. Impairment of tongue function can have significant impact on social interaction and employment. To try and improve speaking and eating in public, the team at the University Health Network is going to use a special device that is designed to help the patient rehabilitate after tongue cancer treatment. The research part of this study is to use a special mouthpiece or mold that is like a partial plate for upper dentures that will fit on the roof of the mouth. This mold is embedded with 62 sensors that will allow patients to visualize their tongue position during speech. With the help of a speech therapist, patients can learn different tongue positions important speaking and eating. This whole process is called biofeedback. The visualization of the tongue gives the patient the flexibility to practice at home to and learn different tongue positions important to eating and speaking. In addition, the device will provide the speech pathologist with an opportunity for easier and more precise assessment of the patient's progress which can reduce the need for visits to the hospital. The investigators expect the biofeedback training to improve the patient's speaking and eating. The study hypothesis is that the biofeedback device will improve speech intelligibility, eating in public, speaking in public, and oral intake scores.
Status | Completed |
Enrollment | 34 |
Est. completion date | December 1, 2022 |
Est. primary completion date | December 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Oral cavity carcinoma involving the tongue or floor of the mouth - Primary surgical treatment or/ - Primary surgical treatment with adjuvant radiation therapy or/ - Salvage surgical treatment - At least 2 weeks post treatment Exclusion Criteria: - Anatomic palate abnormality that precludes fitting a mouthpiece - Cognitively unable to participate in biofeedback - Persistent Cancer - Does not speak English |
Country | Name | City | State |
---|---|---|---|
Canada | University Health Network | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Measure of Obliteration using Oral Volume Assessment Tool (OVAT) | Obliteration of the oral cavity is defined as the ability of the tongue volume to obliterate the oral cavity so that there is space between the tongue and the hard and soft palate. Obliteration is measured using the Oral Volume Assessment Tool (OVAT) which is a measure of displacement. This is an important mechanism of bolus propulsion during the oral phase of swallowing. | Administered at 0, 2, and 4 months | |
Other | Measure of Tongue Protrusion | Protrusion of the tongue is defined as the distance the tongue can be extended beyond the central mandibular incisors measured in millimeters. This is important for the finger function of the tongue. | Administered at 0, 2, and 4 months | |
Other | Measure of Tongue Elevation | Elevation of the tongue is defined as distance the tongue can be moved superiorly above the central mandibular incisors measured in millimeters. The goal is to obtain premaxillary contact. | Administered at 0, 2, and 4 months | |
Other | Fiberoptic Endoscopic Evaluation of Swallow (FEES) | FEES is an assessment that involves placing a flexible endoscope transnasally to obtain a superior view of the pharynx and larynx. The purpose is to evaluate structure & function of the upper aerodigestive tract. This assessment enables visualization nasopharynx, base of the tongue, oropharynx, hypopharynx, and larynx. FEES is used for assessment of retained secretions and retained food consistencies. It is useful for assessing airway protection as it relates to swallowing function. After assessment, FEES is useful for evaluation of the effectiveness of compensatory techniques (postures, maneuvers, bolus modifications) for improving swallowing safety and efficiency. This is a standard of care assessment but is not routinely performed on all OCSCC patients. The surgeon/SLP will use FEES to look at swallowing function and the effectiveness of rehabilitation. | Administered time 0, 2, and 4 months | |
Other | Clinical Speech and Language Assessment | This is documentation of data that would appear in a clinical speech and language consultation. There are parts of the assessment that cannot be performed if the patient does not return to the hospital and the consultation is performed with a video link. These sections of the assessment will be marked "missing data" on the data sheet. | Weekly, Up to 16 weeks | |
Primary | Change in Percent Intelligibility of Speech Over 4 Months | Change in percent intelligibility is measured using Assessment of Intelligibility of Dysarthric Speech (AIDS). Assessment of Intelligibility of Dysarthric Speech (AIDS) is a validated tool that is used in this outcome to measure intelligibility as compared with normal subjects for quantifying single-word intelligibility and sentence intelligibility. | Administered at 0, 2, and 4 months | |
Primary | Change in Rate of Intelligible Speech Over 4 Months | Change in intelligibility rate is also measured using Assessment of Intelligibility of Dysarthric Speech (AIDS). Assessment of Intelligibility of Dysarthric Speech (AIDS) is a validated tool that is used in this outcome to measure speed of language as compared with normal subjects for quantifying speaking rate. | Administered at 0, 2, and 4 months | |
Primary | Change in Speech Acceptability Over 4 Months | Assessment of Speech Acceptability is a qualitative measure of "conversational understandability" of language as compared with normal subjects. Subjects will be given 6-word sentences to read where five naïve listeners will evaluate the speakers' speech acceptability on a scale of 4. This is a subsection of the AIDS test. | Administered at 0, 2, and 4 months | |
Primary | Change in Speech and Swallowing Over 4 Months | This is a disease specific, 6-item, administered questionnaire to evaluate post-treatment speech and swallowing ability measure will provide critical data on the socialization of the patient as it relates to speaking and eating. | Administered at 0, 2, and 4 months | |
Secondary | Change in Patient Satisfaction of EPG Biofeedback Over 4 Months | The patient will be given a self-administered questionnaire to assess satisfaction and adoption of biofeedback. | Administered time 0, 2, and 4 months | |
Secondary | Difference in Cost for Intervention versus Standard of Care Over Time | Hospital, personnel and patient cost will be collected. SLP time will be recorded on time sheets. The fuel and parking cost will be imputed based on the first 3 numbers of the postal code. | Weekly, Up to 16 Weeks |
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